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DENVER – As of Thursday, Colorado will no longer use curative COVID-19 testing in residential care facilities, correctional facilities, shelters and other collective care facilities after new warnings from the State Food and Drug Administration United on false negatives with testing and issues with testing. test.
The Colorado Department of Public Health and Environment said nearly 1,000 such facilities have used the tests in the past three months, and about 70,000 curative tests per week have been performed in the state since. the posting of its contract with the State in early November. .
The state said 715,619 curative tests had been performed in Colorado as of Jan.19.
The CDPHE said it would stop using the test at congregational facilities after warning on January 12 that it was “closely monitoring” the curative test and its administration to people.
The notice came after the FDA issued a security alert that day, warning of false negatives with the test and the improper administration of the test by some vendors. The CDPHE said at the time that the curative test, which received emergency use clearance from the FDA, that it believed the tests would still be “a reliable option under the FDA guidelines.” .
But the department said other concerns from the FDA led them to make the decision announced Thursday.
The latest warning from the FDA regarding curative testing says it should only be used under three conditions: if a person is symptomatic and within 14 days of onset of symptoms; whether sample collection is supervised; and when an oral test gives a negative reading, it must be confirmed by a different method.
In addition to using the tests at some collective care facilities, the state has also used curative testing at several mobile and drive-thru community testing sites set up statewide with local public health departments, including including some larger sites at Denver International Airport. , the Jefferson County Fairgrounds, and the University of Northern Colorado – which were still operating this month.
The CDPHE said on Thursday that it plans to stop using the curative tests at community testing sites in the coming weeks. The department advises people who were tested at curative sites on or after January 13 with an oral swab who tested negative to be retested with a swab from anterior nostrils.
The CDPHE said sites still using curative tests in the meantime should only use them on symptomatic people with anterior nostrils or nasopharyngeal swabs and not oral swabs. He advises asymptomatic people to get tested at a non-curative site.
“We are committed to providing all Colorans with access to reliable testing,” said Sarah Tuneberg, the state’s COVID-19 response testing and containment manager. “It is clear that with the most recent recommendations from the FDA, we must abandon the use of curative tests in collective facilities. We have a transition plan that will allow us to move forward quickly with minimal disruption to testing, which is a critical tool in slowing the spread of COVID-19. We remind Coloradans that testing, while critical, is only one of the tools in our toolbox. We must all continue to follow public health protocols, such as wearing masks, avoiding large gatherings and physical distances. “
The state said it had “no evidence” that Colorado had seen “excessive inaccurate results” as a result of the curative tests and was not aware of any cases in which false negatives were found. leads to more epidemics in collective care facilities.
Other community testing sites operating in January that used curative testing include sites in Park, Clear Creek, Douglas, Jefferson, Logan, Washington, Sedgwick, Morgan, Yuma, Garfield and Montrose counties, but some are no longer operational, according to Curative. site.
Jefferson County Public Health said Thursday afternoon it would no longer offer curative testing and that the Jeffco Fairgrounds site and curative mobile vans at Conifer and Evergreen would be temporarily closed before reopening in partnership with the CDPHE rapid response team.
JCPH said the Jeffco Fairgrounds site will reopen on Saturday and that the Conifer and Evergreen test sites will reopen on their normal Wednesday and Sunday schedules.
“Testing for COVID-19 remains one of the most important tools in the fight against the virus, and JCPH is committed to ensuring that accurate and reliable tests are widely available to our residents,” said Christine Billings, director of the pandemic response office at JCPH. “We want to assure residents that there will be very minimal testing disruption as a result of this change.”
The CDPHE said it was working with its contracts and tax teams, as well as the Colorado attorney general’s office, “to ensure that changes or termination of the contract with Curative are not a cost borne by taxpayers. of Colorado ”.
Curative said in a statement that it was working with the FDA to address the concerns of departments and give them more data to “address these limitations and precautions.” The company said it had no information on CDPHE’s transition plan.
“While we are disappointed with the decision of the Colorado Department of Public Health and Environment to no longer use Curative for testing in Colorado long-term care facilities, we remain confident in our data, our testing and the service we continue to provide to hundreds of thousands of patients every day, ”the company said in the release. “Curative’s test performance and labeling has not changed, and the company has not observed any changes in test performance. The health and safety of patients is of primary concern to Curative and we will strive to ensure a safe and smooth transition for the patients we serve in Colorado. Curative remains committed to providing reliable, convenient and painless COVID-19 tests for those in need. “
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